Observational Study of Dental Outcomes in Head and Neck Cancer Patients

NCT02057510 | Active Not Recruiting DMC

• 2 other identifiers: 12-040-E1U01DE022939-01
• Study Type: observational
• Target: 575
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.

Conditions

Head and Neck Cancer; Dental Disease; Xerostomia; Osteoradionecrosis

Keywords

Head and Neck Cancer; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Tooth loss

  The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer. "Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction: * non-restorable because of fracture or extent of caries; * amputated crown with root remaining; * uncontrolled or persistent periodontal or odontogenic infection.

  Two Years

Secondary Outcomes (10)

• Incidence of exposed intraoral bone

  Two Years

• Extraction complications

  Within 14 days following procedure

• Decayed, Missing or Filled Surfaces (DMFS) Index

  Baseline, 24 months

• Periodontal Measures

  Baseline, 24 months

• Stimulated Salivary Flow Rate

  Baseline, 18 months

Study Arms (1)

Patients receiving head and neck RT

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Head and Neck Radiation Oncology patients

You may qualify if:

• Aged 18 years and older;
• Willing and able to provide signed and dated consent form;
• Diagnosed with head and neck squamous cell carcinoma (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
• Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:
• base of tongue
• buccal/labial mucosa
• epiglottis
• floor of mouth
• gingiva/alveolar ridge
• hard palate
• hypopharynx
• larynx
• lip
• mandible
• maxilla

You may not qualify if:

• Receiving palliative RT;
• History of prior curative RT to the head and neck region to eradicate a malignancy;
• Incarcerated at time of screening;
• Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• University of Minnesota: collaborator
• UConn Health: collaborator
• University of Pennsylvania: collaborator
• Brigham and Women's Hospital: collaborator
• NYU Langone Health: collaborator
• University of North Carolina: collaborator

Study Sites (6)

University of Connecticut Health Center - School of Dental Medicine

Farmington, Connecticut, 06030, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

New York University - College of Dentistry

New York, New York, 10010, United States

Location

University of North Carolina - School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center - Dental Clinic

Charlotte, North Carolina, 28203, United States

Location

University of Pennsylvania - School of Dental Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (15)

• Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Mohammadi K, Long Simpson L, Voelker H, Hodges JS, Lalla RV. Dental disease before radiotherapy in patients with head and neck cancer: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients. J Am Dent Assoc. 2017 Dec;148(12):868-877. doi: 10.1016/j.adaj.2017.09.011.

  PMID: 29173331 RESULT

• Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral complications at 6 months after radiation therapy for head and neck cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. Epub 2017 Aug 3.

  PMID: 28675770 RESULT

• Lalla RV, Long-Simpson L, Hodges JS, Treister N, Sollecito T, Schmidt B, Patton LL, Brennan MT; OraRad Study Group. Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations. BMC Oral Health. 2017 Feb 27;17(1):59. doi: 10.1186/s12903-017-0344-y.

  PMID: 28241807 RESULT

• Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Yang Y, Lin A, Elting LS, Hodges JS, Lalla RV. Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy. Head Neck. 2021 Jan;43(1):164-172. doi: 10.1002/hed.26468. Epub 2020 Sep 29.

  PMID: 32991009 RESULT

• Talevi V, Wen J, Lalla RV, Brennan MT, Mougeot FB, Mougeot JC. Identification of single nucleotide pleomorphisms associated with periodontal disease in head and neck cancer irradiation patients by exome sequencing. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jul;130(1):32-42.e4. doi: 10.1016/j.oooo.2020.02.013. Epub 2020 May 22.

  PMID: 32451231 RESULT

• Mougeot JC, Stevens CB, Almon KG, Paster BJ, Lalla RV, Brennan MT, Mougeot FB. Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study. J Oral Microbiol. 2019 Mar 8;11(1):1586421. doi: 10.1080/20002297.2019.1586421. eCollection 2019.

  PMID: 30891159 RESULT

• Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study. Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):320-330. doi: 10.1016/j.ijrobp.2021.11.021. Epub 2021 Dec 5.

  PMID: 34879248 RESULT

• Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.

  PMID: 35304084 RESULT

• Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Helgeson ES, Lalla RV. Dental Caries Postradiotherapy in Head and Neck Cancer. JDR Clin Trans Res. 2023 Jul;8(3):234-243. doi: 10.1177/23800844221086563. Epub 2022 Apr 11.

  PMID: 35403479 RESULT

• Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.1016/j.oraloncology.2022.105783. Epub 2022 Feb 26.

  PMID: 35231809 RESULT

• Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad). Cancer. 2022 Feb 1;128(3):487-496. doi: 10.1002/cncr.33948. Epub 2021 Oct 19.

  PMID: 34665873 RESULT

• Ward MC, Carpenter MD, Noll J, Carrizosa D, Moeller BJ, Helgeson ES, Lalla RV, Brennan MT. Oncologists' Perspective on Dental Care Around the Treatment of Head and Neck Cancer: A Pattern of Practice Survey. JCO Oncol Pract. 2022 Jan;18(1):e28-e35. doi: 10.1200/OP.20.00913. Epub 2021 Jul 9.

  PMID: 34242067 RESULT

• Threet EJ, Napenas JJ, Petersen C, Mitchell R, Long-Simpson L, Shadick R, Valentino KC, Rybczyk CA, Blake JA, Brown MC, Aidoo R, Helgeson ES, Lalla RV, Brennan MT. Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study participants. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Apr;135(4):501-509. doi: 10.1016/j.oooo.2022.11.011. Epub 2022 Dec 13.

  PMID: 36717342 RESULT

• Lalla RV, Hodges JS, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Brennan MT. Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer. J Am Dent Assoc. 2023 Jun;154(6):519-528.e4. doi: 10.1016/j.adaj.2023.03.009.

  PMID: 37236706 RESULT

• Patton LL, Helgeson ES, Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Lin A, Chera BS, Lalla RV. Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study. Support Care Cancer. 2023 Apr 20;31(5):286. doi: 10.1007/s00520-023-07750-2.

  PMID: 37079106 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatognathic Diseases; Xerostomia; Osteoradionecrosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Michael T Brennan, DDS, MHS

  Wake Forest University Health Sciences

  STUDY CHAIR

• Rajesh Lalla, DDS, PhD

  University of Connecticut Health Center - School of Dental Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: February 1, 2014
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (6)